WOBURN, Mass.--()--Aphios Corporation today announced that it received notification of allowance for a United States Patent entitled “Use of Gingerols for Cancer Patients Suffering from Nausea and Emesis Induced by Chemotherapy.”
“Our scientists and engineers utilized proprietary polarity-guided SuperFluids CXF fractionation technology to establish conditions for the isolation of the active pharmaceutical ingredients and then scaled-up production of gingerols using proprietary SuperFluids CXP manufacturing technology.”
Despite the widespread use of 5-HT3 receptor antagonist anti-emetics such as Palonosetron (Aloxi; Eisai), chemotherapy induced nausea continues to be reported by 70% of adult patients and 58% of children receiving highly emetogenic chemotherapy. Furthermore, these anti-emetics are associated with significant adverse effects such as sedation, extra-pyramidal side effects and hypotension as well as headache, diarrhea and constipation. A desirable attribute in any substitute or additional anti-emetic medication is the absence of clinically significant adverse effects.
Zindol is a highly purified and standardized ginger product. According to Dr. Trevor P. Castor, President and CEO, “Our scientists and engineers utilized proprietary polarity-guided SuperFluids CXF fractionation technology to establish conditions for the isolation of the active pharmaceutical ingredients and then scaled-up production of gingerols using proprietary SuperFluids CXP manufacturing technology.”
Dr. Castor continued, “We recently completed a successful Phase II/III clinical trial on Zindol as an adjuvant to conventional 5-HT3 anti-emetics. This randomized, placebo-controlled, double-blind clinical trial assessed the efficacy of Zindol in treating chemotherapy induced nausea in 576 cancer patients. All doses of Zindol significantly reduced acute nausea severity compared to the placebo. No significant adverse events were reported.”
Aphios plans to conduct a pivotal Phase III clinical trial on Zindol for the adjunctive treatment of nausea in adults undergoing chemotherapy, file an NDA and then initiate a clinical program in a pediatric population. In the interim, the product will be made available as a dietary supplement under the brand name Zindol DS. Zindol will also be developed for nausea caused by surgery, pregnancy, motion sickness and drugs.
Aphios (www.aphios.com) is a clinical stage biotechnology company developing green, enabling technology platforms for improved drug discovery and manufacturing, nanotechnology drug delivery and pathogenic drug safety. Based on these platforms, Aphios is developing enhanced therapeutic products for health maintenance, disease prevention and the treatment of certain cancers, infectious diseases and neurological disorders such as Alzheimer’s disease.